Cardiac Imaging to Predict Embolic Stroke

Overseen By Quintrele Jones, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Atrial fibrillation, Recent stroke, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how certain heart features could predict stroke risk in people without atrial fibrillation, a common heart rhythm disorder. Researchers will use cardiac and brain MRI scans to identify these high-risk features. This approach could help develop better strategies for preventing strokes by identifying individuals who might benefit from blood-thinning treatments. Ideal participants are adults with type II diabetes and a history of heart failure or mini-strokes, but without atrial fibrillation. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to improved stroke prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for cardiac and brain assessment?

Previous studies have shown that heart and brain MRIs are safe for most people. Research indicates that many patients with artificial heart valves can safely undergo MRI scans, as most of these devices are labeled "MR safe."

Gadolinium, the contrast dye used to highlight heart tissue, is usually well-tolerated. Some people might experience minor side effects, such as a cold sensation or a headache, but serious reactions are rare.

Brain MRIs do not use contrast dye, further reducing the risk of side effects. Overall, MRIs are non-invasive and do not use radiation, making them a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cardiac and brain MRI to predict embolic strokes because these imaging techniques offer a detailed look at potential risk factors that standard tests might miss. Unlike traditional methods, cardiac MRI with gadolinium contrast highlights areas of fibrosis in the heart's left atrium, which can be crucial in understanding stroke risks. Additionally, the high-resolution brain MRI sequences provide a precise assessment of any existing embolic lesions, giving a comprehensive view of the patient's condition. This approach could lead to earlier and more accurate predictions of stroke, potentially improving patient outcomes.

What evidence suggests that cardiac and brain MRI is effective for predicting embolic stroke?

Research has shown that MRI (magnetic resonance imaging) for the heart and brain can effectively identify problems that might lead to strokes caused by blood clots. In this trial, all participants will undergo cardiac and brain MRI to evaluate high-risk features. Studies have found that half of the patients with strokes from unknown causes had significant findings on heart MRI, indicating that MRI can identify heart issues potentially causing these strokes. Additionally, using MRI for both the brain and heart can detect early signs of damage in these areas, aiding doctors in planning better treatments. This method is promising because it aims to uncover the true cause of the stroke, potentially leading to improved prevention strategies. ^{1 5 6 7 8}

Who Is on the Research Team?

Nassir Marrouche, MD

Principal Investigator

Tulane School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 without atrial fibrillation but with a high stroke risk score (CHA2DS2VASC ≥3), type II diabetes, or history of heart failure/TIA/stroke from unknown causes. It excludes those who've had recent strokes, are allergic to MRI contrast agents, have certain implants, severe kidney disease, weigh over 300 lbs, or are pregnant/breastfeeding.

Inclusion Criteria

You have a CHA2DS2VASC score of 3 or higher.

I have never had atrial fibrillation.

I have a history of heart failure or stroke with no clear cause.

Exclusion Criteria

You cannot have an MRI scan due to a previous allergic reaction to gadolinium, or if you have a pacemaker, defibrillator, or other devices that are not safe for MRI.

My kidney function is low, with an eGFR under 30 ml/min.

You weigh more than 300 pounds, which could affect the quality of the CMR images.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo Cardiac Magnetic Resonance imaging (CMR) and brain MRI to assess for markers of LA and LAA pathology and embolic-appearing brain infarcts

1 day

1 visit (in-person)

Data Analysis

Analysis of cardiac imaging features and their association with embolic-appearing strokes on brain MRI

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after imaging assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac and Brain MRI

Trial Overview

The study tests if advanced cardiac and brain MRI imaging can predict the risk of embolic strokes in people without atrial fibrillation by identifying specific heart abnormalities that could lead to such strokes.

How Is the Trial Designed?

Group I: Patient arm Experimental Treatment 1 Intervention

All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI

Cardiac and Brain MRI is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Cardiac and Brain MRI for:

• Diagnostic imaging for cardiovascular diseases
• Stroke risk assessment

Approved in United States as Cardiac and Brain MRI for:

• Diagnostic imaging for cardiovascular diseases
• Stroke risk assessment
• Neurological disorders

Approved in Canada as Cardiac and Brain MRI for:

• Diagnostic imaging for cardiovascular diseases
• Stroke risk assessment

Approved in Japan as Cardiac and Brain MRI for:

• Diagnostic imaging for cardiovascular diseases
• Stroke risk assessment

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Published Research Related to This Trial

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.

The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

Cardiovascular MRI is primarily used to assess major blood vessels, but it is increasingly important for evaluating heart-specific conditions like intracardiac masses and congenital heart disease.

The non-invasive nature of MRI allows for detailed three-dimensional imaging of cardiovascular anatomy, suggesting its future role will expand significantly in diagnosing and investigating heart-related pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of cardiac and pericardial disease. Croisille, P., Revel, D.[2016]

Magnetic resonance imaging (MRI) is effective for detecting and measuring valvular heart disease, including both regurgitation and stenosis, which are critical for diagnosing and managing these conditions.

MRI also allows for the assessment of left ventricular size and function, as well as monitoring changes over time or in response to treatment, making it a valuable tool in the ongoing management of patients with valvular heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Valvular heart disease. Duerinckx, AJ., Higgins, CB.[2017]

Magnetic resonance (MR) imaging has become a valuable tool in medical imaging, but its safety in patients with cardiovascular devices requires careful consideration and screening.

Extensive data from ex vivo, animal, and clinical studies provide guidelines for safely performing MR examinations in these patients, emphasizing the need for thorough patient assessment and risk-benefit analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Levine, GN., Gomes, AS., Arai, AE., et al.[2016]

Recent advancements in cardiac MR imaging have significantly improved the speed and detail of assessments, allowing for broader clinical applications beyond just structural analysis to include functional and perfusion evaluations.

This review highlights the effectiveness of cardiac MR in diagnosing various acquired heart diseases, such as ischemic heart disease and cardiomyopathy, showcasing its role in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac disease in the adult: MR evaluation. Bluemke, DA., Halefoglu, AM.[2004]

Cardiovascular MR imaging is a safe and effective tool for evaluating the heart and blood vessels, providing high-quality images and unique data on heart function and metabolism.

Advancements in imaging speed and the development of new contrast agents are expected to enhance the capabilities and applications of cardiovascular MR imaging in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physics and technology of cardiovascular MR imaging. Axel, L.[2019]

Cardiovascular MRI is a noninvasive imaging technique that provides high-resolution, three-dimensional images of the heart, making it an effective tool for diagnosing cardiovascular diseases without exposing patients to ionizing radiation.

This imaging method allows for the differentiation between infarcted and non-infarcted heart tissue and enables the quantification of heart function and blood flow, highlighting its utility in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging: cardiological diagnosis]. Buser, PT.[2006]

Cardiovascular magnetic resonance (CMR) is becoming essential in cardiology, providing precise assessments of heart function and structure, particularly for conditions like ischemic heart disease and heart failure.

The growing accessibility and expertise in CMR outside specialized centers enhance patient care by allowing for detailed evaluations, including unique assessments like myocardial iron overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. Valbuena-López, S., Hinojar, R., Puntmann, VO.[2017]

Cardiovascular MRI is primarily used to evaluate major vessels, but it is increasingly important for assessing specific heart conditions like intracardiac masses, pericardial disease, and congenital heart disease.

The non-invasive nature of MRI allows for detailed three-dimensional imaging and functional assessment of the heart, suggesting its growing significance in clinical practice and research in the coming years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of the heart: functional imaging. Croisille, P., Revel, D.[2020]

Cardiac magnetic resonance imaging (MRI) is particularly valuable for assessing ventricular function, especially in cases where other imaging methods may not provide optimal results.

Recent advancements in cardiac MRI allow for direct, high-resolution imaging of infarcted heart tissue, offering critical insights that other imaging techniques may not capture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: what can it add clinically in 2004? Klocke, FJ.[2019]

Cardiac MR imaging is highly effective for assessing heart anatomy, function, and identifying issues like infarcted myocardium and coronary artery stenoses, outperforming other imaging methods.

Despite its advantages, cardiac MR imaging is not widely used in clinical practice due to various challenges in establishing a clinical program, as discussed based on the authors' experiences in both inpatient and outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting up a clinical cardiac MR imaging program: practical issues and economics. Wolff, SD., Comeau, CR.[2019]

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